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MS Trial Alert: Investigators Recruiting for Study of Oral ADS-5102 (amantadine) extended release capsules for People with MS and Walking Impairment

March 20, 2019

SUMMARY: Investigators are recruiting a total of 570 people with all types of MS for a study to determine whether investigational oral ADS-5102 (amantadine) extended release capsules improve walking speed compared with inactive placebo. Participants will continue on any disease-modifying treatment throughout the study. This study is funded by Adamas Pharmaceuticals, Inc.
 
DETAILS

ADS-5102 (amantadine extended release capsules) is an extended release formulation of amantadine, a molecule used to prevent or treat certain influenza infections. Amantadine also regulates nervous system activity, and is FDA-approved to treat Parkinson's disease symptoms as well as certain side effects caused by drugs. ADS-5102 is approved to treat dyskinesia (abnormal, uncontrolled, involuntary movement) in people with Parkinson’s disease receiving levodopa-based therapy. This phase 3 study is being conducted to assess the effectiveness and safety of ADS-5102 (amantadine) extended release capsules (an oral medication) in people with MS who have walking impairment. A previous phase 2 clinical trial of ADS-5102, was conducted in people with MS and walking impairment. The phase 2 study data warranted further research of ADS-5102 on walking speed. ( MS Journal, published online 2018 Jan 1)
 
Eligibility and Details: Investigators are seeking participants who have been diagnosed with any type of MS, ages 18 to 70. Participants’ current medication regimen must be stable for at least 30 days prior to screening, and must continue to be stable for the duration of the study. Participants will be excluded if they have been unable to tolerate amantadine in the past, if they have had an MS relapse with onset less than 30 days prior to screening, or if they have used dalfampridine or amantadine within 30 days prior to screening. Further enrollment criteria apply and are available from the contact below.
 
Participants will be randomly assigned to receive one of three oral treatments: ADS-5102 (274 mg), ADS-5102 (137 mg), or placebo once daily at bedtime for 21 weeks. The primary outcomes being measured are walking speed, as measured by the Timed 25-Foot Walk. Secondary outcomes include other measures of walking speed and ability, as well as safety.
 
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact clinicaltrials@adamaspharma.com.
 
Sites are enrolling in the following cities:
Cullman, Alabama
Phoenix, Arizona
Scottsdale, Arizona
Tucson, Arizona
Carlsbad, California
Fresno, California
Fullerton, California
Newport Beach, California
Long Beach, California
Sacramento, California
Aurora, Colorado
Colorado Springs, Colorado
Denver, Colorado
Fort Collins, Colorado
Fairfield, Connecticut
New London, Connecticut
Washington, District of Columbia
Maitland, Florida
Miami, Florida
Naples, Florida
Orlando, Florida
Ormond Beach, Florida
Palm Coast, Florida
Port Charlotte, Florida
Sarasota, Florida
Saint Petersburg, Florida
Tampa, Florida
Vero Beach, Florida
Atlanta, Georgia
Savannah, Georgia
Northbrook, Illinois
Indianapolis, Indiana
Kansas City, Kansas
Lenexa, Kansas
Overland Park, Kansas
Lexington, Massachusetts
Foxboro, Massachusetts
Worcester, Massachusetts
Detroit Michigan
Farmington Hills, Michigan
Golden Valley, Minnesota
Saint Louis, Missouri
Kansas City, Missouri
Great Falls, Montana
Lincoln, Nebraska
Omaha, Nebraska
Las Vegas, Nevada
Albuquerque, New Mexico
Amherst, New York
Lake Success, New York
New York, New York
Patchogue, New York
Plainview, New York
Rochester, New York
Staten Island, New York
Charlotte, North Carolina
Raleigh, North Carolina
Cleveland, Ohio
Columbus, Ohio
Centerville, Ohio
Oklahoma City, Oklahoma
Portland, Oregon
Philadelphia, Pennsylvania
Charleston, South Carolina
Greer, South Carolina
Indian Land, South Carolina
Spartanburg, South Carolina
Cordova, Tennessee
Franklin, Tennessee
Johnson City, Tennessee
Lubbock, Texas
Houston, Texas
Round Rock, Texas
Salt Lake City, Utah
Newport News, Virginia
Norfolk, Virginia
Kirkland, Washington
Seattle, Washington
Milwaukee, Wisconsin 

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
 
Without participants in research studies, MS research would come to a standstill. Read more here.
 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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